The aim of this study is to determine the usefulness of a portable, meditation-based intervention called the Mantram Repetition Program (MRP) for Veterans with military-related posttraumatic stress disorder (PTSD). This study will compare the individual delivery of the MRP to Present-Centered Individual Therapy (PCIT) at two sites in San Diego, CA and Bedford, MA.

PTSD symptom severity is measured by CAPS to determine PTSD diagnosis. The scale rates 17 items representing the Diagnostic and Statistical Manual IV (DSM-IV) criteria B (re-experiencing), C (avoidance/numbing) and D (hyper-arousal). CAPS has demonstrated high levels of internal consistency, good inter-rater reliability, & excellent convergent validity. The F1/I2 rule will be applied to establish the diagnosis of PTSD aligned with DSM-IV (e.g. one symptom of Criterion B, three of Criterion C, and two of Criterion D. The CAPS also includes an item to assess duration of PTSD symptoms.

The FACIT-SWB was developed to assess spiritual components (e.g., harmony, meaning, purpose in life, peacefulness, faith/assurance) of quality of life using 23 items rated on a 5-point Likert scale. Higher scores indicating greater spiritual well-being. Validity has been demonstrated by significant Pearson correlations between measures of quality of life, mood, and religious growth. It has demonstrated internal consistency reliability.

FFMQ a 39-item scale that measures five components of mindfulness: observing; describing; acting with awareness; non-judging of inner experience; and non-reactivity to inner experience. FFMQ scores have mediated the effect of mindfulness training on positive changes in psychological state.

ISI is a widely used measure of insomnia with well-established reliability and validity. It consists of seven items, three of which assess severity of insomnia (i.e., degree of difficulty falling asleep, staying asleep, and waking too early). The remaining questions tap satisfaction with sleep pattern, effect of sleep on daytime and social functioning, and concern about current sleep difficulties. Both categorical and continuous measures of sleep difficulties can be assessed. Items are rated on a 0-4 Likert scale. Total scores range from 0-28 and results are interpreted as 0-7 = no clinically significant insomnia, 8-14 = sub-threshold insomnia, 15-21 = moderately severe clinical insomnia (moderate severity) and 21-28 = severe clinical insomnia.

VRSF-12 is a brief version of the SF-36, assessing two broad domains of physical and mental health status (Physical Component Score, PCS and Mental Component Score, MCS). These instruments were adapted for use in the VHA by increasing the number of response options resulting in fewer floor and ceiling effects, increased reliability, and greater explanatory power over the original versions of the instrument. They are among the most widely used functional status measures in the world and have been shown to be highly reliable and valid. Reliability estimates for the PCS-12=.80 and for the MCS-12=.76.

The PTGI is a 21-item, 6-point Likert scale self-report measure (0 = �I did not experience this change as a result of my crisis� to 5 = �I experienced this change to a very great degree as a result of my crisis�). There are five domains of growth: I. Relating to Others; II. New Possibilities; III. Personal Strength; IV. Spiritual Change; and V. Appreciation of Life. Higher scores are indicative of greater growth.

A portable meditation-based "Mantram Repetition Program (MRP)" will be delivered individually in 8-weekly 1 hour sessions to teach a set of strategies for training attention to manage symptoms. For this study, the program targets symptoms of posttraumatic stress disorder (PTSD) in Veterans who have experienced military-related trauma.

Behavioral: Mantram Repetition Program (MRP)

The MRP includes three strategies for training attention and managing symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. In this study, it is delivered individually in 8 weekly 1 hour sessions that consist of information, experiential learning and homework. A "mantram" is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal. The unique focus on spiritual words is linked to what one might call inner spiritual resources.

Other Name: MRP

Active Comparator: Arm 2

Present Centered Individual Therapy (PCIT) is a form of individually delivered 8 weekly, 1 hour sessions that are problem-oriented to improve current coping. For this study, it serves as an attention control arm for the non-specific effects of individual therapist interaction.

Behavioral: Present Centered Individual Therapy (PCIT)

The PCIT is a form of individual therapy that is problem-oriented to improve current coping. It typically avoids actual details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training.

Other Name: PCIT

Detailed Description:

The investigators aim to conduct a rigorous test of the therapeutic treatment efficacy of the Mantram Repetition Program (MRP) by offering it as a stand-alone intervention, compared to an attention control arm, in a more diverse sample of Veterans with post-traumatic stress disorder (PTSD) who will be recruited from a variety of clinics, including primary care, women's health and specialty clinics in two geographical locations. A prospective, randomized, two-site clinical trial will be conducted to compare the effect of the MRP to that of Present Centered Individual Therapy on scores of the Clinician Administered PTSD Scale (CAPS) and PTSD Checklist-Military (PCL-M) at three time-points (pre-treatment, post-treatment at 8 weeks and at follow-up or 16 weeks). The investigators propose to address the following aims: To examine the MRP as a stand-alone intervention for efficacy in treating Veterans with PTSD; To examine MRP as stand-alone intervention for efficacy in treating trauma-related psychological distress (depression, insomnia, anger) in Veterans with PTSD; To examine MRP as a stand-alone intervention for efficacy in improving mental health, quality of life, spiritual well-being, mindfulness and posttraumatic growth.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

18 years of age or older

Read and write English fluently

Traumatic event related to military-duty, including combat, military training accidents, and military sexual trauma

Transportation to attend meetings and available to complete study protocols

Cognitive impairment sufficient to cause inability to complete the protocol

Psychotic symptoms

Dementia or other organic mental disorders that may cause inability to complete the protocol

Significant documented alcohol/substance abuse

Presence of severe suicidal urges or intent

Residence in a geographical area outside of San Diego County or Bedford, MA area

Current daily practice of any skills of any meditation-based program - including, but not limited to:

Transcendental Meditation (TM)

yoga

Tai Chi

Qi-Gong

Vipassana

Loving-Kindness Meditation

Mindfulness-Based Stress Reduction

or other mindfulness intervention

guided imagery

mantram repetition

passage meditation

walking meditation

Zen or Buddhist meditation

self-hypnosis, bio-feedback, etc.

Other participant circumstances that, in the opinion of a consensus of study team, would interfere with the safety of a prospective participant or their need for treatment.

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01506323